Observational Study of Persistence on Bafiertam Treatment In Routine Clinical Practice
Sponsored by Banner Life Sciences LLC
About this trial
Last updated 2 years ago
Study ID
Status
Type
Placebo
Accepting
Not accepting
Trial Timing
Ended 6 months ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
1. Male or non-pregnant female aged 18 years and older.
2. Participants diagnosed with Relapsing forms of multiple sclerosis R(RMS) and satisfy the approved therapeutic indication for Bafiertam per the approved product labeling.
3. Participants may enroll if they are within 90 days of initiating therapy with Bafiertam.
4. Female participants of childbearing potential must practice effective contraception from Day -1 and be willing and able to continue contraception for the duration of the study.
5. Willing and able to sign the informed consent form (ICF) approved by the Institutional Review Board (IRB).
6. Willing and able to complete all the study procedures and communicate meaningfully with study personnel.
Exclusion Criteria
1. Known hypersensitivity to fumarates including dimethyl fumarate, Tecfidera, and/or diroximel fumarate (Vumerity) or Bafiertam.
2. Participated in another clinical trial within 30 days, suffered or still recovering from a medically significant event of surgery within 30 days, or previously participated in a clinical study with a similar investigational product.